NCT01325987

Brief Summary

Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency, the investigators propose to determine if vitamin D treatment improves glycemic control in vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D treatment will improve glycemic control and ß-cell function in vitamin D deficient AA subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional glycemic control effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

March 28, 2011

Last Update Submit

January 16, 2014

Conditions

Type 2 DiabetesVitamin D Deficiency

Keywords

Type 2 diabetesVitamin D deficiencyGlycemic control

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    glycemic control

    3 -4 months

Secondary Outcomes (1)

  • AUC for c-peptide and glucose after MMTT

    3- 4months

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.

Other: Sugar pill

vitamin D2

EXPERIMENTAL

Subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.

Dietary Supplement: Vitamin D2

Interventions

Vitamin D2DIETARY_SUPPLEMENT

Subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.

Also known as: Group 1: vitamin D2 50000 IU weekly once for 8 weeks
vitamin D2
Sugar pillOTHER

1. group: vitamin D2 50000 IU weekly once for 8 weeks 2. nd group: placebo weekly once for 8 weeks

sugar pill

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Type 2 DM with acanthosis
  • African American
  • years
  • BMI\> 85%
  • Tanner Stage \> 4

You may not qualify if:

  • Those taking vitamin D
  • Pregnancy
  • Those with chronic health conditions other than diabetes
  • Those who are deemed medically unstable to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Vitamin D Deficiency

Interventions

ErgocalciferolsSugars

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCarbohydrates

Study Officials

  • Ambika Ashraf, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

US(1)